Radi PressureWire Aeris, Руководство пользователя

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TRANSMITTER LIGHT INDICATORS
Light indicators
Explanation
Green steady light Transmitter on
Green pulsating light
proportional to blood pressure Normal operation
Yellow steady light PressureWire® disconnected from transmitter.
Re-insert PressureWire® firmly into transmitter.
Green pulsating light &
Yellow slow blinking light
Battery level low
It is recommended to finish case or to exchange
PressureWire®.
Yellow fast blinking light Error. Possible cause:
o
Battery level too low for operation
o
Internal error
Attempt restart by removing PressureWire from
body and turn the transmitter off and on again.
COMPLIANCE WITH REGULATORY REQUIREMENTS
Hereby, Radi Medical Systems AB, declares that this PressureWire® is in
compliance with the essential requirements and other relevant provisions of Medical
Device Directive (93/42/EEC), Radio and Telecommunications Terminal Directive
(199/5/EC) and QSR
Guidance and manufacturer's declaration - electromagnetic emissions
PressureWire® system is intended for use in the electromagnetic environment specified below. The
customer or the user of PressureWire® system should assure that it is in such an environment.
Emission test Compliance Electromagnetic environment -
guidance
RF emissions
CISPR 11
Group 1
The PressureWire® system uses RF energy only
for its internal function. Therefore, its RFemissions
are very low and are
not likely to cause any
interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations
/flicker emissions
IEC 61000-3-3
Complies
The PressureWire® system is suitable for use in all
establishments including domestic establishments
and those directly connected to the public low-
voltage power supply network that supplies building
for domestic purposes.
Guidance and manufacturer's declaration - electromagnetic immunity
The PressureWire® system is intended for use in the electromagnetic environment specified below.
The customer or the user of the PressureWire® system should assure that it is in such an
environment.